Healthcare Industry Developments | BioTuesdays by Kilmer Lucas IR

Developments

FDA fast tracks Vistagen’s PH10 for major depressive disorder

The FDA granted Vistagen (NASDAQ:VTGN) fast track designation for development of PH10, an investigational nasal sprays, for the treatment of major depressive disorder (MDD). The FDA decision aligns with “our belief in...

December 6, 2022

Developments

Hepion completes enrollment early in Phase 2 ALTITUDE-NASH liver function trial

Hepion Pharmaceuticals (NASDAQ:HEPA) completed enrollment of 60 non-alcoholic steatohepatitis (NASH) stage 3 (F3) subjects in the Phase 2 ALTITUDE-NASH clinical trial. The trial is being conducted in collaboration with...

December 5, 2022

Developments

iBio to showcase RubrYc discovery engine at antibody conference

iBio (NYSEA:IBIO) will present two posters about its intelligence-powered RubrYc discovery engine at the Antibody Engineering and Therapeutics Conference in San Diego on Dec. 4-8. The conference features the latest...

December 5, 2022

Developments

EF Hutton adds four analysts to healthcare research team

EF Hutton announced a series of strategic hires enhancing the company’s healthcare equity research department, including Tony Butler, Ph.D., senior managing director; Elemer Piros, Ph.D., managing director; Fozia Ahmed...

November 30, 2022

Developments

First Wave files IND for enhanced microgranule delivery of adrulipase

First Wave BioPharma (NASDAQ:FWBI) submitted an IND application seeking authorization from the FDA to evaluate an enhanced enteric microgranule delivery formulation of adrulipase as a treatment for exocrine pancreatic...

November 30, 2022

Developments

Context Therapeutics selects antibody for Claudin 6-positive solid tumors

Context Therapeutics (NASDAQ:CNTX) announced the selection of CTIM-76, a T-cell-engaging bispecific antibody, as its lead clinical development candidate to target Claudin 6 (CLDN6) positive cancers, resulting from its...

November 29, 2022

Developments

PharmaJet receives NIH grant for HPV needle-free immunization study

Closely-held PharmaJet received an $800,000-plus direct to Phase 2 grant from the NIH to evaluate the immunogenicity of intradermal administration of human papilloma virus (HPV) vaccine using the company’s Tropis...

November 29, 2022

Developments

Enrollment tops 25% in Femasys FemaSeed de novo trial

Femasys (NASDAQ:FEMY) completed more than 25% of its targeted enrollment of 214 patient fertility cycles in its FemaSeed de novo trial. FemaSeed is the first and only first-line approach in development designed to...

November 29, 2022

Developments

FDA grants fast tract to Aravive’s batiraxcept for ccRCC

The FDA granted fast track designation to Aravive’s (NASDAQ:ARAV) lead program, batiraxcept, for the treatment of patients with advanced or metastatic clear cell renal cell carcinoma (ccRCC) who have progressed after...

November 29, 2022

Developments

TC BioPharm begins dosing Phase 2b AML study

TC BioPharm (NASDAQ:TCBP) began dosing the first three patients in its Phase 2b ACHIEVE clinical trial of OmnImmune, an allogeneic unmodified cell therapy focused on treating acute myeloid leukemia (AML). The initial...

November 22, 2022

Developments

Palisade Bio gets FDA fast track for return of bowel function after GI surgery

The FDA granted fast tract designation to Palisade Bio’s (NASDAQ:PALI) LB1148 for the acceleration of time to return of bowel function following surgery. By inhibiting the activity of digestive proteases, the company...

November 22, 2022

Developments

IntelGenx receives FDA PDUFA date for RIZAFILM

The FDA accepted for review IntelGenx’s (TSX:IGX; OTCQB:IGXT) Class 2 response to a 2020 complete response letter for the company’s 505(b)(2) NDA for RIZAFILM VersaFilm for the treatment of acute migraine. The FDA has...

November 22, 2022

Developments

Kiora doses first patient in Phase 1b retinitis pigmentosa trial

Kiora Pharmaceuticals (NASDAQ:KPRX) dosed the first patient in a first-in-human open-label clinical trial for KIO-301, intended to restore vision loss in patients with retinitis pigmentosa, a rare, inherited genetic eye...

November 17, 2022

Developments

Azura posts positive Phase 2b results in meibomian gland dysfunction

Azura Ophthalmics reported positive 3-month efficacy and safety results from its Phase 2b study of AZR-MD-001 0.5% in meibomian gland dysfunction (MGD), a leading cause of dry eye disease and contact lens discomfort...

November 17, 2022

Developments

NeuroSense receives IND clearance for Phase 2b ALS study

The FDA cleared NeuroSense Therapeutics’ (NASDAQ:NRSN) IND for its Phase 2b PARADIGM study with its lead drug candidate, PrimeC, in the treatment of amyotrophic lateral sclerosis (ALS). PARADIGM is currently enrolling...

November 15, 2022

Developments

Raymond James sees high likelihood of CPT-1 reimbursement for Profound’s TULSA-PRO

Analyst Rahul Sarugaser, Ph.D., writes that there is a high likelihood that Profound Medical (NASDAQ:PROF) will receive a category-1 CPT code from the Centers for Medicare and Medical Services when it files an...

November 15, 2022

Developments

TauRx’s announcement of positive Phase 3 LUCIDITY results triggers $119-million (U.S.) in warrant exercises

Closely-held TauRx Therapeutics of the UK received $119-million through an exercise of warrants triggered by the announcement of the Phase 3 LUCIDITY results in October, supporting hydromethylthionine mesylate (HMTM)...

November 15, 2022

Developments

Lanier Biotherapeutics receives U.S. patent for IL-25 binding molecules

Lanier Biotherapeutics announced that the United States Patent and Trademark Office has issued U.S. Patent 11,492,397, entitled, “Neutralizing Monoclonal Antibodies to IL-25 and Uses Thereof.” The patent covers...

November 14, 2022

Developments

Lantheus, POINT Biopharma to commercialize PNT2002 & PNT2003

Lantheus Holdings (NASDAQ:LNTH) and POINT Biopharma Global (NASDAQ:PNT) announced a set of strategic collaboration agreements in which Lantheus would license exclusive worldwide rights to POINT’s PNT2002 and PNT2003...

November 14, 2022

Developments

Oramed to commercialize oral insulin in Korea with Medicox

Oramed Pharmaceuticals (NASDAQ, TASE:ORMP) signed an exclusive commercial distribution agreement for the Republic of Korea with Medicox, an emerging biotech company with proven partnerships in the Korea. The agreement...

November 14, 2022

Developments

CytoSorbents appears to validate Sigyn’s therapeutic strategy

CytoSorbents (NASDAQ:CTSO) has received a research grant from a division of the NIH to test the ability of its existing polymers to remove cytokines and lipopolysaccharide (LPS) endotoxin from septic porcine plasma, a...

November 10, 2022

Developments

IntelGenx in feasibility, development agreement for CBD-infused VetaFilm for pets

IntelGenx (TSX:IGX; OTCQB:IGXT) entered into a feasibility study and development agreement with an undisclosed animal health company focused on advancing a VetaFilm-based oral film formulation containing CBD for use in...

November 9, 2022

FDA fast tracks Vistagen’s PH10 for major depressive disorder

Hepion completes enrollment early in Phase 2 ALTITUDE-NASH liver function trial

iBio to showcase RubrYc discovery engine at antibody conference

EF Hutton adds four analysts to healthcare research team

First Wave files IND for enhanced microgranule delivery of adrulipase

Context Therapeutics selects antibody for Claudin 6-positive solid tumors

PharmaJet receives NIH grant for HPV needle-free immunization study

Enrollment tops 25% in Femasys FemaSeed de novo trial

FDA grants fast tract to Aravive’s batiraxcept for ccRCC

TC BioPharm begins dosing Phase 2b AML study

Palisade Bio gets FDA fast track for return of bowel function after GI surgery

IntelGenx receives FDA PDUFA date for RIZAFILM

Kiora doses first patient in Phase 1b retinitis pigmentosa trial

Azura posts positive Phase 2b results in meibomian gland dysfunction

NeuroSense receives IND clearance for Phase 2b ALS study

Raymond James sees high likelihood of CPT-1 reimbursement for Profound’s TULSA-PRO

TauRx’s announcement of positive Phase 3 LUCIDITY results triggers $119-million (U.S.) in warrant exercises

Lanier Biotherapeutics receives U.S. patent for IL-25 binding molecules

Lantheus, POINT Biopharma to commercialize PNT2002 & PNT2003

Oramed to commercialize oral insulin in Korea with Medicox

CytoSorbents appears to validate Sigyn’s therapeutic strategy

IntelGenx in feasibility, development agreement for CBD-infused VetaFilm for pets

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